The following data is part of a premarket notification filed by Xre Corp. with the FDA for Omni Plane System.
| Device ID | K854085 |
| 510k Number | K854085 |
| Device Name: | OMNI PLANE SYSTEM |
| Classification | Table, Radiographic, Tilting |
| Applicant | XRE CORP. 300 FOSTER ST. Littleton, MA 01460 |
| Contact | Donna Glencross |
| Correspondent | Donna Glencross XRE CORP. 300 FOSTER ST. Littleton, MA 01460 |
| Product Code | IXR |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-07 |
| Decision Date | 1985-10-28 |